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Designing the next-generation clinical care pathway for Alzheimer’s disease

Nature Aging volume 2, pages 692–703 (2022)Cite this article

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Abstract

The reconceptualization of Alzheimer’s disease (AD) as a clinical and biological construct has facilitated the development of biomarker-guided, pathway-based targeted therapies, many of which have reached late-stage development with the near-term potential to enter global clinical practice. These medical advances mark an unprecedented paradigm shift and requires an optimized global framework for clinical care pathways for AD. In this Perspective, we describe the blueprint for transitioning from the current, clinical symptom-focused and inherently late-stage diagnosis and management of AD to the next-generation pathway that incorporates biomarker-guided and digitally facilitated decision-making algorithms for risk stratification, early detection, timely diagnosis, and preventative or therapeutic interventions. We address critical and high-priority challenges, propose evidence-based strategic solutions, and emphasize that the perspectives of affected individuals and care partners need to be considered and integrated.

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Fig. 1: The next-generation clinical care pathway for Alzheimer’s disease.

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Acknowledgements

R.A.’s grant support includes National Institutes of Health (NIH) grants (AG062109, AG068753, AG072654 and AG063635). Additional support was provided by the American Heart Association (20SFRN35360180 and 20SFRN35490098), the Alzheimer’s Drug Discovery Foundation (201902-2017835) and Gates Ventures. W.M.v.d.F received support from the Research of Alzheimer center Amsterdam, which is part of the neurodegeneration research program of Amsterdam Neuroscience. The chair of W.v.f.F is supported by the Pasman stichting. W.F. is a recipient of ABOARD, which is a public–private partnership receiving funding from ZonMW (73305095007) and Health~Holland, Topsector Life Sciences & Health (PPP allowance, LSHM20106). More than 30 partners participate in ABOARD. H.W. receives research grant from the National Brain Project funded by the Ministry of Science and Technology, China (2021ZD0201805). C.C. is supported by the National Medical Research Council of Singapore (MOH-000707-00, NMRC/OFLCG/2019, NMRC/CIRG/1485/2018 and NMRC/CSA-SI/0007/2016). The Gérontopôle (chair B.V.) has received research grant support from the European Commission as well as industries including Biogen, Green Valley Pharmaceuticals, Novo Nordisk, Pfizer, Pierre-Fabre, Roche, Lily and Eisai. J.C. is supported by NIGMS grant P20GM109025, NINDS grant U01NS093334, NIA grants R01AG053798, P20AG068053 and R35AG71476 and the Alzheimer’s Disease Drug Discovery Foundation. A.S. receives support from multiple NIH grants (P30 AG010133, P30 AG072976, R01 AG019771, R01 AG057739, U01 AG024904, R01 LM013463, R01 AG068193, T32 AG071444, U01 AG068057 and U01 AG072177). The authors thank D. Henley for his contribution to the critical revision of the Perspective. Medical writing support was provided by L. O’Brien of CMC AFFINITY, McCann Health Medical Communications and was funded by Eisai.

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Authors and Affiliations

  1. Neurology Business Group, Eisai, Nutley, NJ, USA

    Harald Hampel, Min Cho, Susan De Santi, Peng Gao, Ricky Kurzman & Andrea Vergallo

  2. Depts of Anatomy & Neurobiology, Neurology and Epidemiology, Boston University Schools of Medicine and Public Health, Boston, MA, USA

    Rhoda Au

  3. Center for Improving Chronic Illness Care, University of Southern California, San Diego, San Diego, CA, USA

    Soeren Mattke

  4. Alzheimer Center Amsterdam, Depts of Neurology and Epidemiology and Data Science, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands

    Wiesje M. van der Flier

  5. Alzheimer’s Therapeutic Research Institute, University of Southern California, San Diego, San Diego, CA, USA

    Paul Aisen

  6. Departments of Neurology, Radiology, Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA

    Liana Apostolova

  7. Memory Aging and Cognition Centre, Departments of Pharmacology and Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore

    Christopher Chen

  8. Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan

    Atsushi Iwata

  9. Indiana Alzheimer’s Disease Research Center and the Departments of Radiology and Imaging Sciences, Medical and Molecular Genetics, and Neurology, Indiana University School of Medicine, Indianapolis, IN, USA

    Andrew J. Saykin

  10. Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), Rostock, Germany

    Stefan Teipel

  11. Department of Psychosomatic Medicine, University Medical Center Rostock, Rostock, Germany

    Stefan Teipel

  12. University Paul Sabatier, Gerontopole, Toulouse University Hospital, UMR INSERM 1285, Toulouse, France

    Bruno Vellas

  13. Dementia Care and Research Center, Peking University Institute of Mental Health (Sixth Hospital), National Clinical Research Center for Mental Disorders, Beijing, China

    Huali Wang

  14. Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada, Las Vegas (UNLV), Las Vegas, NV, USA

    Jeffrey Cummings

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  1. Harald Hampel
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Contributions

H.H., A.V., S.D.S. and P.G. developed the initial concept and theoretical framework for this Perspective. All authors contributed to researching the literature and data, discussing the content, and writing, reviewing and/or editing of the Perspective.

Corresponding author

Correspondence to Harald Hampel.

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Competing interests

H.H. is an employee of Eisai and serves as senior associate editor for the Journal Alzheimer’s & Dementia and has not received any fees or honoraria since May 2019. H.H. is inventor of 11 patents and has received no royalties for: In Vitro Multiparameter Determination Method for The Diagnosis and Early Diagnosis of Neurodegenerative Disorders patent no. 8916388; In Vitro Procedure for Diagnosis and Early Diagnosis of Neurodegenerative Diseases patent no. 8298784; Neurodegenerative Markers for Psychiatric Conditions publication no. 20120196300; In Vitro Multiparameter Determination Method for The Diagnosis and Early Diagnosis of Neurodegenerative Disorders publication no. 20100062463; In Vitro Method for The Diagnosis and Early Diagnosis of Neurodegenerative Disorders publication no. 20100035286; In Vitro Procedure for Diagnosis and Early Diagnosis of Neurodegenerative Diseases publication no. 20090263822; In Vitro Method for The Diagnosis of Neurodegenerative Diseases patent no. 7547553; CSF Diagnostic in Vitro Method for Diagnosis of Dementias and Neuroinflammatory Diseases publication no. 20080206797; In Vitro Method for The Diagnosis of Neurodegenerative Diseases publication no. 20080199966; Neurodegenerative Markers for Psychiatric Conditions publication no. 20080131921; Method for diagnosis of dementias and neuroinflammatory diseases based on an increased level of procalcitonin in cerebrospinal fluid: US patent no. 10921330. R.A. is a scientific advisor to Signant Health and consultant to Biogen. S.M. serves on the board of directors of Senscio Systems and the scientific advisory board of AiCure Technologies, and Boston Millennia Partners, and has received consulting fees from AARP, Biogen, Biotronik, Bristol-Myers Squibb, C2N, Eisai and Roche. Research programs of W.M.v.d.F. have been funded by ZonMW, NWO, EU-FP7, EU-JPND, Alzheimer Nederland, CardioVascular Onderzoek Nederland, Health~Holland, Topsector Life Sciences & Health, stichting Dioraphte, Gieskes-Strijbis fonds, stichting Equilibrio, Pasman stichting, stichting Alzheimer & Neuropsychiatrie Foundation, Biogen MA, Boehringer Ingelheim, Life-MI, AVID, Roche BV, Fujifilm and Combinostics. W.F. holds the Pasman chair. W.F. is a recipient of ABOARD, which is a public–private partnership receiving funding from ZonMW (73305095007) and Health~Holland, Topsector Life Sciences & Health (PPP allowance, LSHM20106). W.F. has performed contract research for Biogen MA and Boehringer Ingelheim. W.F. has been an invited speaker at Boehringer Ingelheim, Biogen MA, Danone, Eisai, WebMD Neurology (Medscape) and Springer Healthcare. W.F. is consultant to Oxford Health Policy Forum CIC, Roche and Biogen MA. W.F. participated in advisory boards of Biogen MA and Roche. All funding is paid to the institution of W.F. W.F. was associate editor of Alzheimer, Research & Therapy in 2020/2021. W.F. is associate editor at Brain. P.A. reports research agreements with Janssen, Lilly and Eisai, grants from NIA, the Alzheimer’s Association and FNIH and consulting fees from Biogen, Roche, Merck, Abbvie, Immunobrain Checkpoint, Rainbow Medical and Shionogi. L.A. has provided consultation to Eli Lilly, Biogen, Eisai, GE Healthcare and Two Labs. L.G.A. receives research support from NIA U01 AG057195, NIA R01 AG057739, NIA P30 AG010133, Alzheimer Association LEADS GENETICS 19-639372, Roche Diagnostics RD005665, AVID Pharmaceuticals and Life Molecular Imaging. L.G.A. received honoraria for participating in independent data safety monitoring boards and providing educational CME lectures and programs. L.G.A. has stock in Cassava Sciences and Semiring. C.C. receives research grants from the National Medical Research Council of Singapore. C.C. also receives research support from Moleac, Roche, Eisai and Lundbeck; and has participated in advisory boards for Cerecin and Eisai in the past 3 years. A.I. receives research grant from AMED (Japanese Agency for Medical Research), JSPS (Japan Society for Promotion of Science), Eisai, Daiichi Sankyo, Shionogi, Chugai-Roche and Kyowa Kirin. A.I. also receives consultant fees from Eisai, Biogen and Janssen Pharmaceuticals. A.I. also receives lecture fees from Eisai, Daiichi Sankyo, Otsuka, Ono Pharmaceutical and Fujirebio. A.S. received support from Avid Radiopharmaceuticals, a subsidiary of Eli Lilly (in kind contribution of PET tracer precursor), Bayer Oncology (Scientific Advisory Board), Eisai (Scientific Advisory Board), Siemens Medical Solutions USA (Dementia Advisory Board) and Springer Nature Publishing (Editorial Office Support as Editor-in-Chief, Brain Imaging and Behavior). S.T. has served on the advisory boards of Roche, Biogen, Eisai and Grifols within the last 3 years. B.V. has served as consultant/advisor to Eisai, Biogen, Lilly, Longeveron, Novo Nordisk, TauRx P and Roche in the past 3 years. A.V. declares no competing interests related to the present paper and the contribution of A.V. to this paper reflects entirely and only A.V.’s own academic expertise on the matter. A.V. was an employee of Eisai (November 2019–June 2021). A.V. did not receive any fees or honoraria since November 2019. Before November 2019, A.V. received lecture honoraria from Roche, MagQu and Servier. H.W. has provided consultation to Eisai, Lundbeck, Roche and Signant Health pharmaceutical and assessment companies. H.W. owns the copyright of the individualized management system of neuropsychiatric symptoms (NPSIMS) and the smartphone-based application of brief cognitive screening kit (shairenzhi). J.C. provided consultation to AB Science, Acadia, Alkahest, AlphaCognition, ALZPathFinder, Annovis, AriBio, Artery, Avanir, Biogen, Biosplice, Cassava, Cerevel, Clinilabs, Cortexyme, Diadem, EIP Pharma, Eisai, GatehouseBio, GemVax, Genentech, Green Valley, Grifols, Janssen, Karuna, Lexeo, Lilly, Lundbeck, LSP, Merck, NervGen, Novo Nordisk, Oligomerix, Ono, Otsuka, PharmacotrophiX, PRODEO, Prothena, ReMYND, Renew, Resverlogix, Roche, Signant Health, Suven, Unlearn AI, Vaxxinity, VigilNeuro pharmaceutical, assessment and investment companies. M.C., S.D.S., P.G. and R.K. are employees of Eisai.

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Hampel, H., Au, R., Mattke, S. et al. Designing the next-generation clinical care pathway for Alzheimer’s disease. Nat Aging 2, 692–703 (2022). https://doi.org/10.1038/s43587-022-00269-x

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